Atorvastatin Calcium Tablets 20 mg — Class III drug recall D-0419-2018
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-02-07, distributed nationwide. Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Imp
| Recall number | D-0419-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2018-01-29 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-12-07 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 55111-0121, 55111-0121-05, 55111-0121-10, 55111-0121-30, 55111-0121-60, 55111-0121-90, 55111-0122, 55111-0122-05, 55111-0122-10, 55111-0122-30, 55111-0122-60, 55111-0122-90, 55111-0123, 55111-0123-05, 55111-0123-10, 55111-0123-30, 55111-0123-60, 55111-0123-90 |
Product
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
Reason for recall
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0419-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.